Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | CONT |
AYALA SENDER Inés ( S&D)
|
ZDECHOVSKÝ Tomáš ( PPE),
FITTO Raffaele ( ECR),
ALI Nedzhmi ( ALDE),
JÁVOR Benedek ( Verts/ALE),
VALLI Marco ( EFDD),
KAPPEL Barbara ( ENF)
|
| Committee Opinion | ENVI |
LA VIA Giovanni ( PPE)
|
Mireille D'ORNANO ( ENF),
Gerben-Jan GERBRANDY ( ALDE),
Julie GIRLING ( ECR),
Karin KADENBACH ( S&D)
|
Lead committee dossier:
Subjects
Events
PURPOSE: to grant discharge to the European Medicines Agency (EMA) for the financial year 2015.
NON-LEGISLATIVE ACT: Decision (EU) 2017/1681 of the European Parliament on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2015.
CONTENT: with this Decision, the European Parliament gives discharge to the Executive Director of the European Medicines Agency for the implementation of the Agency’s budget for 2015.
The Decision is consistent with the European Parliament’s resolution adopted on 27 April 2017 and includes a series of observations that form an integral part of the discharge decision (refer to the summary of the opinion of 27 April 2017).
Amongst Parliament’s main observations in the resolution accompanying the discharge decision, it noted that 2015 marked the 20th anniversary of the Agency and the 50th anniversary of pharmaceutical legislation in the Union. Parliament observed that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects.
While welcoming the information provided by the Agency to the discharge authority on its current contractual commitments and liabilities linked to its physical presence in the UK, Parliament noted with concern that the Agency's rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. The Agency is asked to report to the discharge authority on any developments on this matter.
The resolution also highlighted that although there had been delays in the collection of fees as noted by the discharge authority, these had no impact on the Agency's and Member States' ability to perform their public health tasks, including pharmacovigilance activities.
Parliament acknowledged from the Agency that the revised policy on the handling of declarations of interests of scientific committees' members and experts entered into force in 2015. The revised policy on handling of declared interests of members of staff of the Agency and candidates before recruitment was finalised in October 2016.
Moreover, an anti-fraud office was established as part of its anti-fraud strategy.
Lastly, Parliament encouraged the Agency to further raise awareness of its conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as obligatory items to be discussed during recruitment procedures and performance reviews.
The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the budget of Agency for the financial year 2015.
The vote on the decision on discharge covers the closure of the accounts (in accordance with Annex IV, Article 5 (1) (a) to Parliament’s Rules of Procedure).
Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2015 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 510 votes to 101 with 13 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies .
These recommendations may be summarised as follows:
Agency’s financial statements : Parliament noted the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : It acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. Parliament also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.
Communication : Parliament noted that in 2015, the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances. It stressed that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other authorised substance.
Parliament reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminded the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. Therefore, due to the special vulnerabilities of those tests, Parliament asked the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries , in accordance with the law.
It underlined that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented.
Adaptive pathways : Parliament noted that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation. It is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines. It asked the Agency to report to the discharge authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission.
Impact of Brexit : Parliament stated that on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. It noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. It observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.
Lastly, Parliament noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. It asked the Agency to report to the discharge authority on any developments on this matter.
The Committee on Budgetary Control adopted the report by Inés AYALA SENDER (S&D, ES) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015.
The committee called on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the agency’s budget for the financial year 2015.
Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2015 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts. They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies :
Agency’s financial statements : Members note the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : Members acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. They reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines. They also reminded it of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. The Agency is asked to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically.
Members also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.
Impact of Brexit : on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. Members noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. They observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.
Lastly, Members noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. They asked the Agency to report to the discharge authority on any developments on this matter.
Having examined the revenue and expenditure accounts for the financial year 2015 and the balance sheet as at 31 December 2015 of the European Medicines Agency (EMA), as well as the Court of Auditors' report on the annual accounts of the Agency for the financial year 2015, accompanied by the Agency's replies to the Court's observations, the Council recommended the European Parliament to give a discharge to the Executive Director of the Agency in respect of the implementation of the budget for the financial year 2015.
The Council welcomed the Court's opinion that the Agency's annual accounts present fairly its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of the Agency's Financial Regulation, and that the underlying transactions for 2015 are legal and regular in all material respects.
Nevertheless, it made one observation:
fees : the Council encouraged the Agency to continue implementing the Court's recommendations from last year as regards the respect of due dates for the collection of fees and the related payments to national competent authorities.
PURPOSE: presentation of the EU Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2015, together with the Agency’s reply.
CONTENT: in accordance with the tasks conferred on the Court of Auditors by the Treaty on the Functioning of the European Union, the Court presents to the European Parliament and to the Council, in the context of the discharge procedure, a Statement of Assurance as to the reliability of the annual accounts of each institution, body or agency of the EU, and the legality and regularity of the transactions underlying them, on the basis of an independent external audit.
This audit concerned, amongst others, the annual accounts of the European Medicines Agency (EMA). In brief, the Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use.
Statement of assurance : pursuant to the provisions of Article 287 of the Treaty on the Functioning of the European Union (TFEU), the Court has audited:
the annual accounts of the Agency, which comprise the financial statements and the reports on the implementation of the budget for the financial year ended 31 December 2015, and the legality and regularity of the transactions underlying those accounts.
Opinion on the reliability of the accounts : in the Court’s opinion, the Agency’s annual accounts present fairly, in all material respects, its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation and the accounting rules adopted by the Commission’s accounting officer.
Opinion on the legality and regularity of the transactions underlying the accounts : in the Court’s opinion, the transactions underlying the annual accounts for the year ended 31 December 2015 are legal and regular in all material respects.
The report did not make any particular comments apart from stating that the elements taken into consideration in the report do not take account of the referendum results of 23 June 2016 on the UK vote to leave the EU (and the consequences this may have on the Agency whose headquarters is located in London) as the Court had presented its report before this date.
Lastly, the Court of Auditors’ report contains a summary of the Agency’s key figures in 2015 :
Budget : EUR 304 million. Staff : 775 including officials, temporary and contract staff and seconded national experts.
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure.
Analysis of the accounts of the European Medicines Agency (EMA) .
CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.
The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed.
From 2014 onwards, the Commission classifies its expenditure as follows:
Direct management : the budget is implemented directly by the Commission services. Indirect management : the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies .
Shared management : under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions.
This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.
It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge.
Discharge procedure : the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU.
The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge.
The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.
Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA).
The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.
As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015:
Commitment appropriations :
- committed : EUR 308 million;
- paid : EUR 290 million;
- carried-over : EUR 6 million.
Payment appropriations:
- committed : EUR 349 million;
- paid : EUR 291 million;
- carried-over : EUR 43 million.
For further details on expenditure, please refer to the final accounts of the EMA .
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure.
Analysis of the accounts of the European Medicines Agency (EMA) .
CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.
The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed.
From 2014 onwards, the Commission classifies its expenditure as follows:
Direct management : the budget is implemented directly by the Commission services. Indirect management : the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies .
Shared management : under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions.
This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.
It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge.
Discharge procedure : the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU.
The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge.
The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.
Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA).
The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.
As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015:
Commitment appropriations :
- committed : EUR 308 million;
- paid : EUR 290 million;
- carried-over : EUR 6 million.
Payment appropriations:
- committed : EUR 349 million;
- paid : EUR 291 million;
- carried-over : EUR 43 million.
For further details on expenditure, please refer to the final accounts of the EMA .
Documents
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament: T8-0172/2017
- Debate in Parliament: Debate in Parliament
- Committee report tabled for plenary: A8-0084/2017
- Amendments tabled in committee: PE599.891
- Committee opinion: PE592.296
- Supplementary non-legislative basic document: 05873/2017
- Committee draft report: PE593.883
- Court of Auditors: opinion, report: OJ C 449 01.12.2016, p. 0123
- Court of Auditors: opinion, report: N8-0124/2016
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document: COM(2016)0475
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document published: COM(2016)0475
- Non-legislative basic document: EUR-Lex COM(2016)0475
- Court of Auditors: opinion, report: OJ C 449 01.12.2016, p. 0123 N8-0124/2016
- Committee draft report: PE593.883
- Supplementary non-legislative basic document: 05873/2017
- Committee opinion: PE592.296
- Amendments tabled in committee: PE599.891
Activities
- Monica MACOVEI
Plenary Speeches (1)
Votes
A8-0084/2017 - Inés Ayala Sender - Résolution #
GUE/NGL
NI| Amendments | Dossier |
| 46 |
2016/2169(DEC)
2016/12/14
ENVI
24 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Recalls that, as stipulated in its financial regulation, budget revenue of the European Medicines Agency ('the Agency') is based on cash received for contributions from the Union, fees for circulation and marketing authorisation applications for pharmaceutical products and for post- authorisation activities as well as for various administrative activities;
Amendment 10 #
Draft opinion Paragraph 6 a (new) 6a. Calls on the Agency to pay special attention to the protection of whistleblowers in the context of Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure1 a; _________________ 1a OJ L 157, 15.6.2016, p. 1.
Amendment 11 #
Draft opinion Paragraph 6 b (new) 6b. Calls for an overall improvement in the prevention of, and the fight against, corruption through a holistic approach, commencing with better public access to documents and more stringent rules on conflicts of interest, the introduction or strengthening of transparency registers and the provision of sufficient resources for law enforcement measures, and also through improved cooperation among Member States and with relevant third countries;
Amendment 12 #
Draft opinion Paragraph 6 c (new) 6c. Encourages the Agency further to raise awareness of the conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as an obligatory item to be discussed during recruitment procedures and performance reviews;
Amendment 13 #
Draft opinion Paragraph 7 7. Notes that in 2015 the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances; stresses that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other substance authorised
Amendment 14 #
Draft opinion Paragraph 7 7.
Amendment 15 #
Draft opinion Paragraph 7 a (new) 7 a. Notes that the Agency launched a pilot project on "adaptive pathways" in March 2014; recalls that that project aims to accelerate marketing approvals for some specific medicines but raises numerous public health concerns; by shifting the burden of evidence from pre- marketing to post-marketing authorisation, the procedure in that pilot project can undermine the safety assessment of medicines; recalls that assessment of acceleration of authorisations in the United States has shown that more medicines were withdrawn once they had been put on the market, while the French independant medicine "Journal Prescrire" reported that, since 2006, 27% of the medicines authorised through an accelerated procedure in the Union were "unacceptable"1a _________________ 1a (Prescrire, april 2016, n°390, p.295)
Amendment 16 #
Draft opinion Paragraph 7 a (new) 7 a. Underlines that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented;
Amendment 17 #
Draft opinion Paragraph 7 b (new) 7 b. Recommends the Agency to develop impact indicators; believes that such impact indicators are essential tools in order to measure the effectiveness of the Agency;
Amendment 18 #
Draft opinion Paragraph 8 8. Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use, and emphasises, in that connection, that the Agency must pay close attention to the findings of independent and reliable scientific analyses and that a failure to do so may give rise to serious risks to public health in the EU;
Amendment 19 #
Draft opinion Paragraph 8 8. Reiterates the
Amendment 2 #
Draft opinion Paragraph 2 2. Notes that in 2015 the total budget of the Agency was EUR 304 000 000, of which only EUR 18 669 000 had been made available through the core funding directly from the general budget of the European Union;
Amendment 20 #
Draft opinion Paragraph 8 a (new) 8 a. Recalls that the workload of the Agency is constantly growing and reflected in the budgetary increases in income from fees charged to applicants; notes with concern that the imposed staff cuts in recent years included staff working on tasks financed by applicants' fees without regard to the workload involved; strongly supports, therefore, the introduction of flexibility in adjusting the number of establishment plan posts for staff working on tasks financed by applicants' fees, in line with increasing demand;
Amendment 21 #
Draft opinion Paragraph 8 a (new) 8a. Emphasises, in that connection, that the failure to take account of independent scientific analyses seems to have been glaring in the case of vaccines against the papilloma virus and their undesirable side effects;
Amendment 22 #
Draft opinion Paragraph 8 b (new) 8 b. Stresses the risk of budgetary volatility faced by the Agency as a consequence of the outcome of the UK referendum on Union membership; proposes, in the spirit of sound financial management, that the Agency be authorised to maintain a budgetary reserve to respond to unforeseen costs and unfavourable exchange rate fluctuation that may need to be incurred in 2017, or beyond, as a consequence of that decision, to ensure that the Agency can continue to carry out its tasks effectively;
Amendment 23 #
Draft opinion Paragraph 8 c (new) 8 c. Acknowledges that the Agency launched a pilot project in March 2014 on the safe use of adaptive pathways; notes that that pilot project aims to identify the appropriate tools within the current regulatory framework to bring to market medicines that address unmet medical needs for a defined patient population, and to ensure that marketing authorisation will only be granted if there is a positive balance of benefits and risks, without compromising patient safety or changing the standards of regulatory approval;
Amendment 24 #
Draft opinion Paragraph 9 9. Recommends, on the basis of the facts available,
Amendment 3 #
Draft opinion Paragraph 2 a (new) 2a. Emphasises, in that connection, that the significant share of its budget drawn from private sources raises the question of the independence of the Agency vis-à-vis the pharmaceutical industry;
Amendment 4 #
Draft opinion Paragraph 2 a (new) 2 a. Notes that the budget of EMA does not allow the Agency to have experts fully independent from the pharmaceutical industry;
Amendment 5 #
Draft opinion Paragraph 2 b (new) 2 b. Notes that several experts of the Agency still have links with the pharmaceutical industry, notably through grants;
Amendment 6 #
Draft opinion Paragraph 2 c (new) 2 c. Notes that the conflict of interests' policy of the Agency still needs to be improved, despite its 2015 reform; notes furthermore that revolving doors are not prevented since there is no cooling-off period for experts receiving grants from the private sector before joining the Agency and after leaving it;
Amendment 7 #
Draft opinion Paragraph 3 3.
Amendment 8 #
Draft opinion Paragraph 3 a (new) 3a. Emphasises that Brexit constitutes a new challenge for the Agency, which will have to cope with a change of seat that will necessitate many decisions concerning the management of its staff;
Amendment 9 #
Draft opinion Paragraph 4 a (new) 4a. Calls on the Agency to enhance its procedures and practices aimed at safeguarding the financial interests of the Union and to actively contribute to a results-oriented discharge process;
source: 595.702
2017/03/06
CONT
22 amendments...
Amendment 1 #
Proposal for a decision 1 1 Paragraph 1 1. Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year
Amendment 10 #
Motion for a resolution Paragraph 7 7. Observes that the revised policy on handling of declared interests of staff members of EMA and candidates before recruitment was finalised in October 2016; notes that th
Amendment 11 #
Motion for a resolution Paragraph 7 a (new) 7a. Urges the Agency to put in place rules on revolving doors, establishing dissuasive sanctions, such as the reduction of pension, and prohibiting its board members and staff for at least three years after leaving the Agency to take employment in bodies related to medicines; only integrity upholds the public trust;
Amendment 12 #
Motion for a resolution Paragraph 12 12. Takes note that the Agency has adopted the Commission guidelines on internal whistleblowing in November 2014; notes also that the Agency is currently working on a policy to handle external sources’ reports on matters within the scope of its responsibilities (i.e. external whistleblowing rules), and that approval of this new policy is planned to occur by the end of 2017; welcomes this policy which should strengthen even further the Agency’s efforts to disseminate a culture of integrity and compliance in the preparation and submission of regulatory documents; therefore, urges the Agency to put in place external rules on whistle- blowing; recommends the Agency to disseminate those rules among its staff so that all employees to be aware of them; asks the Agency to provide details on the whistle-blower cases in 2015 (if any) and how they were handled and finalised;
Amendment 13 #
Motion for a resolution Paragraph 14 a (new) Amendment 14 #
Motion for a resolution Paragraph 14 a (new) 14a. Asks the Agency to provide the discharge Authority with the list of meetings with lobbyists and the minutes of these meetings;
Amendment 15 #
Motion for a resolution Paragraph 15 a (new) 15a. Notes that the Agency receives information concerning suspected adverse reactions to medicines from the competent authorities in the Member States and from pharmaceutical companies; calls on the Agency to make public every disclosure of adverse reaction reports, clinical studies, and trial reports;
Amendment 16 #
Motion for a resolution Paragraph 15 b (new) 15b. Welcomes the PRIME project, a scheme launched by the Agency to enhance support for the development of medicines that target an unmet medical need; invites the Agency to ensure, for the welfare of the citizens, an accurate and adequate policy in the field of pharmacovigilance, in order to avoid a premature authorisation of medicines which are being tested;
Amendment 17 #
Motion for a resolution Paragraph 15 c (new) 15c. Calls hence on the Commission to review and update its policy on pharmacovigilance which entered into force in 2012.
Amendment 18 #
Motion for a resolution Paragraph 21 a (new) 21a. Notes that in 2014, the Agency concluded a EUR 15 million framework contract for high-level consultancy services (covering the 2014-2017 period); The objectives and activities to be carried out were not sufficiently specific to justify the procurement decision or the volume of the contract; points out that there is no evidence that the Management Board had been consulted on the procurement decision, which would have been more appropriate given the nature and value of the contract, even though the Financial Regulation does not require it;
Amendment 19 #
Motion for a resolution Paragraph 23 23. Welcomes the information provided by the Agency to the discharge authority on its current contractual commitments and liabilities linked to its physical presence in the UK; notes with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347,6 million; acknowledges that the absence of a break clause was noted in the opinion of the Committee on Budgets of 24 May 2011 and that the rental agreement was signed in 2011 when a potential exit of the UK from the Union was not foreseeable; however, the costs associated with the relocation would reasonably be expected to be considered in the negotiations on the withdrawal agreement between the Union and the UK Government; asks the Agency to report to the discharge authority on any developments on this matter;
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 20 #
Motion for a resolution Paragraph 23 a (new) 23a. Stresses the risk of budgetary volatility faced by the Agency as a consequence of the outcome of the UK referendum on Union membership; proposes, in the spirit of sound financial management, that the Agency be authorised to maintain a budgetary reserve to respond to unforeseen costs and unfavourable exchange rate fluctuation that may need to be incurred in 2017, or beyond, as a consequence of that decision, to ensure that the Agency can continue to carry out its tasks effectively; asks also in this respect for the Agency to produce a comprehensive Business Continuity Plan which deals with the double and connected risks of budgetary and business volatility;
Amendment 21 #
Motion for a resolution Paragraph 23 a (new) 23a. With regard to new headquarters of the Agency, calls on the Commission and the stakeholders to ensure the independence of the Agency, guarantying a correct negotiation with the Member States, and keeping out of that negotiation the pharmaceutical companies;
Amendment 22 #
Motion for a resolution Paragraph 23 a (new) 23a. Notes that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation; is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines; asks the Agency to report to the Discharge Authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission;
Amendment 3 #
Proposal for a decision 2 2 Paragraph 1 1. Approves the closure of the accounts of the European Medicines Agency for the financial year
Amendment 4 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 5 #
Motion for a resolution Citation 1 a (new) - having regard to the special report No 15/2012 of the Court of Auditors entitled ‘Management of conflict of interest in selected EU Agencies’,
Amendment 6 #
Motion for a resolution Paragraph 3 a (new) 3a. Notes that the relevant legislation, regulates the deadlines by which payments to the national competent authorities (NCAs) are to be issued; notes from the Court’s report that the Agency did not meet these deadlines for most of the transactions audited by the Court; calls on the Agency to meet deadlines for payments in favour of the NCAs;
Amendment 7 #
Motion for a resolution Paragraph 5 a (new) 5a. Recalls that the workload of the Agency is constantly growing and reflected in the budgetary increases in income from fees charged to applicants; notes with concern that the imposed staff cuts in recent years included staff working on tasks financed by applicants’ fees without regard to the workload involved; strongly supports, therefore, the introduction of flexibility and coherence in adjusting the number of establishment plan posts for staff working on tasks financed by applicants’ fees, in line with increasing demand;
Amendment 8 #
Motion for a resolution Paragraph 5 a (new) 5a. Notes that jobs open for applications have been published without a deadline date, and in some cases, the publication dates back to 2010; calls on the Agency to update its vacancies applications and to ensure more transparency in order to complete recruitment procedures;
Amendment 9 #
Motion for a resolution Paragraph 6 a (new) 6a. Notes with concern, that despite the 2015 reform, the Agency’s conflict of interests’ policy remains flexible; is especially concerned that revolving doors for experts receiving grants from the private sector have not been prohibited, in the context of the reform for both being hired at the Agency and for the post- employment period;
source: 599.891
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